OsteoporosisPhase 3NCT00000412
Osteoporosis Prevention After Heart Transplant
A Phase 3 study testing Alendronate and Calcitriol in people with Osteoporosis and Cardiac Transplantation, run by Columbia University at 2 sites in United States.
Trial summary
During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Osteoporosis, Cardiac Transplantation
- What is being tested?
- Alendronate and Calcitriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 1997to Apr 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac transplantation
Who cannot join
- Active peptic ulcer disease, gastrectomy, inflammatory bowel disease, malignancy, Paget's disease of bone, osteogenesis imperfecta, multiple myeloma, primary hyperparathyroidism, rheumatoid arthritis, Cushing's syndrome, or thyrotoxicosis
- Suppressive doses of thyroid hormone, anticonvulsant drugs, past bisphosphonate therapy, current calcitonin therapy, or fluoride therapy
- Cirrhosis, inflammatory liver disease, or nephrolithiasis
- Serum creatinine > 2.5 mg/dl
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbai University Medical Center
New York, New York, 10032
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Prevention of Osteoporosis After Cardiac Transplantation
During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant.
In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
Read the detailed description
We will enroll patients who have undergone cardiac transplantation into a randomized, double-blind, 12-month study of the efficacy and safety of calcitriol (Rocaltrol) and alendronate sodium (Fosamax) in the prevention of bone loss after transplantation. We will give all participants standard pre- and post-transplantation management and immunosuppressive therapy, three tablets of calcium citrate (Citracal + D, each containing 315 mg of elemental calcium and 200 IU of vitamin D), and a multivitamin providing 400 units of vitamin D daily. We will randomize participants to one of two active treatment groups within 1 month of transplantation. We will give Group A active alendronate (10 mg/day) and placebo calcitriol. We will give Group B placebo alendronate and active calcitriol (0.25 micrograms BID). The primary efficacy endpoint is the change in spine bone mineral density (BMD) during the first 6 months after transplantation. The secondary efficacy endpoint is the change in hip BMD during the first year after transplantation. We will also monitor the incidence of vertebral fracture.
We will invite eligible subjects to participate in the study. We will offer patients who elect not to participate in the therapeutic trial the opportunity to have serial BMD measurements at the same intervals as treated subjects and to be followed as untreated controls. We will continue recruitment until we have randomized a total of 146 cardiac transplant recipients. We will perform bone densitometry at randomization (unless performed within the previous month) and at 6 and 12 months. We will obtain radiographs (x-rays) at randomization and will repeat them at 12 months to detect undiagnosed vertebral fractures.
- Conditions
- Osteoporosis, Cardiac Transplantation
- Being tested
- Alendronate, Calcitriol, Placebo Alendronate, Placebo Calcitriol
- Keywords
- Osteoporosis, Osteopenia, Heart transplant, Bone fracture, Bone density, Dual energy x-ray absorptiometry
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
CalcitriolDrug
Placebo AlendronateDrug
Placebo CalcitriolDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A active alendronate (10 mg/day) and placebo calcitriol. Receives: Drug: Alendronate; Drug: Placebo Calcitriol |
| Group B | Placebo comparator | We will give Group B placebo alendronate and active calcitriol (0.25 micrograms BID). Receives: Drug: Calcitriol; Drug: Placebo Alendronate |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startSep 1997
- Primary completionApr 2002
- Study completionApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Elizabeth Shane, MD, Principal investigator, Columbia University Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000412
- Sponsor's protocol ID
- R01AR046124
- Other IDs
- R01AR046124, NIAMS-008
- Status last verified
- Jul 2015
- First submitted
- 3 Nov 1999
- Last updated
- 7 Jul 2015
- Results posted
- No
Publications
Shane E, Addesso V, Namerow PB, McMahon DJ, Lo SH, Staron RB, Zucker M, Pardi S, Maybaum S, Mancini D. Alendronate versus calcitriol for the prevention of bone loss after cardiac transplantation. N Engl J Med. 2004 Feb 19;350(8):767-76. doi: 10.1056/NEJMoa035617.
PubMed 14973216
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Osteoporosis After Cardiac Transplantation
- ClinicalTrials.gov ID
- NCT00000412
- Acronym / sponsor ID
- R01AR046124
- Conditions
- Osteoporosis, Cardiac Transplantation
- Keywords
- Osteoporosis, Osteopenia, Heart transplant, Bone fracture, Bone density, Dual energy x-ray absorptiometry
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Merck Sharp & Dohme LLC
- Study start
- Sep 1997
- Primary completion
- Apr 2002 (actual)
- Study completion
- Apr 2002 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant.
In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
Detailed description
We will enroll patients who have undergone cardiac transplantation into a randomized, double-blind, 12-month study of the efficacy and safety of calcitriol (Rocaltrol) and alendronate sodium (Fosamax) in the prevention of bone loss after transplantation. We will give all participants standard pre- and post-transplantation management and immunosuppressive therapy, three tablets of calcium citrate (Citracal + D, each containing 315 mg of elemental calcium and 200 IU of vitamin D), and a multivitamin providing 400 units of vitamin D daily. We will randomize participants to one of two active treatment groups within 1 month of transplantation. We will give Group A active alendronate (10 mg/day) and placebo calcitriol. We will give Group B placebo alendronate and active calcitriol (0.25 micrograms BID). The primary efficacy endpoint is the change in spine bone mineral density (BMD) during the first 6 months after transplantation. The secondary efficacy endpoint is the change in hip BMD during the first year after transplantation. We will also monitor the incidence of vertebral fracture.
We will invite eligible subjects to participate in the study. We will offer patients who elect not to participate in the therapeutic trial the opportunity to have serial BMD measurements at the same intervals as treated subjects and to be followed as untreated controls. We will continue recruitment until we have randomized a total of 146 cardiac transplant recipients. We will perform bone densitometry at randomization (unless performed within the previous month) and at 6 and 12 months. We will obtain radiographs (x-rays) at randomization and will repeat them at 12 months to detect undiagnosed vertebral fractures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Alendronate, Drug: Placebo CalcitriolGroup A active alendronate (10 mg/day) and placebo calcitriol. |
| Group B | Placebo comparator | Drug: Calcitriol, Drug: Placebo AlendronateWe will give Group B placebo alendronate and active calcitriol (0.25 micrograms BID). |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac transplantation
Key exclusion criteria (4 listed)
- Active peptic ulcer disease, gastrectomy, inflammatory bowel disease, malignancy, Paget's disease of bone, osteogenesis imperfecta, multiple myeloma, primary hyperparathyroidism, rheumatoid arthritis, Cushing's syndrome, or thyrotoxicosis
- Suppressive doses of thyroid hormone, anticonvulsant drugs, past bisphosphonate therapy, current calcitonin therapy, or fluoride therapy
- Cirrhosis, inflammatory liver disease, or nephrolithiasis
- Serum creatinine > 2.5 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alendronate | Drug | Group A |
| Calcitriol | Drug | Group B |
| Placebo Alendronate | Drug | Group B |
| Placebo Calcitriol | Drug | Group A |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
- Background: PubMed 14973216Shane E, Addesso V, Namerow PB, McMahon DJ, Lo SH, Staron RB, Zucker M, Pardi S, Maybaum S, Mancini D. Alendronate versus calcitriol for the prevention of bone loss after cardiac transplantation. N Engl J Med. 2004 Feb 19;350(8):767-76. doi: 10.1056/NEJMoa035617.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Shane, MD principal investigator
Columbia University Department of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alendronate and Calcitriol in people with Osteoporosis and Cardiac Transplantation, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.